VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 0944189
Sex: M
Age: 44
State: TN

Vax Date: 12/27/2020
Onset Date: 01/14/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: I experienced a fast heartbeat at about 10 minutes after the shot. I did a few deep inhale/exhale repetitions to calm it down. I think this lasted less than 1 minute. I did not have other symptoms.

Other Meds: Lisinopril 40MG

Current Illness: no

ID: 0944190
Sex: F
Age: 45
State: TX

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: BP 169/94 P 94

Allergies: NKDA

Symptoms: Chest pain, anxiety and numbness to right hand x 10 minutes

Other Meds: Lisinopril

Current Illness:

ID: 0944191
Sex: F
Age: 15
State: OH

Vax Date: 12/27/2020
Onset Date: 12/27/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies: NKDA

Symptoms: Wrong Dose of Vaccine - Too High; symptoms lasted 0 days

Other Meds:

Current Illness:

ID: 0944192
Sex: F
Age: 63
State: MN

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: none

Allergies: none

Symptoms: 20 hrs after injection, I started sweating, felt very nauseated, chills and headache. It only lasted 5 minutes

Other Meds: calcium, Vit. E , zinc, Paxil, Lipitor, Estridial, Progesterone cream

Current Illness: none

ID: 0944193
Sex: F
Age: 29
State: TX

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: None- mostly subsided within 24 hours

Allergies: Penicillin and sulfa drugs

Symptoms: Shooting chest pains, delirium, dry mouth/throat with mild difficulty swallowing, severe weakness, severe fatigue, sweating.

Other Meds: Cymbalta

Current Illness: None

ID: 0944194
Sex: F
Age: 34
State: AR

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fever

Other Meds:

Current Illness:

ID: 0944195
Sex: M
Age: 55
State: AZ

Vax Date: 11/05/2020
Onset Date: 01/13/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Not seen the Doctor yet.

Allergies: No

Symptoms: Pain at the injection site, he reports he also has pain radiating into the shoulder. Not clear how these symptoms occurring from injection site in Deltoid region. I make sure the injection is administered in the mid point of Deltoid muscle (at lest 3 fingers width below from the shoulder joint), not too close to the shoulder joint. Not clear why he took this long to report. When asked when the symptoms began, he said the symptoms began post vaccination, He did not see any provider yet, he said he will see his doctor in the near future and will let us know.

Other Meds: Glipizide, Losartan, Amlodipine, Tadalafil,

Current Illness: Diabetes, Hypertension.

ID: 0944196
Sex: F
Age: 40
State: CA

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: no

Allergies: no

Symptoms: Beginning feeling tingle on the tonged, 10-20 sec. Soreness at the inj site. 2hrs later tired. Little nausea. 1/14/21 bad nausea, cold hot sweats, flu like symptoms. Nasal congestion and fatigue. Symptoms are trickling in not all at once.

Other Meds: no

Current Illness: no

ID: 0944197
Sex: F
Age: 58
State: MT

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Body Aches, Headache, Sore Arm, Diarrhea

Other Meds:

Current Illness:

ID: 0944198
Sex: F
Age: 32
State: NC

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies: Surgical tape

Symptoms: Really high fever of 103.5 for 2 days, headach, very bad muscle pain, fever chills, and my arm that the shot was in felt a burning sinsation.

Other Meds: Gabapiten and hydroxyzine.

Current Illness: Interstitial cystitis

ID: 0944199
Sex: F
Age: 82
State: FL

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Error: Wrong Dose of Vaccine - Too High

Other Meds:

Current Illness:

ID: 0944200
Sex: F
Age:
State: CO

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:97.6-98.1; Comments: normal for her; Test Name: pulse ox; Result Unstructured Data: Test Result:92-95 %; Comments: good

Allergies:

Symptoms: flushing/ felt feverish and it was not a rash, she just felt flushed; hot/ felt really hot; soreness in the arm; little headache; experiencing tingling in hands and feet (mostly in feet); experiencing tingling in hands and feet (mostly in feet) and they feel cold; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route on left upper arm at single dose for COVID-19 immunization on 05Jan2021, 12:30pm at 60-year-old. Medical history included: ongoing diabetes type 2; ongoing gout; went through menopause 10 years ago (2011). She had pulmonary emboli 3 years ago (2018) and had some scar tissue but not on oxygen though she did get short of breath. No relevant family medical history. The only reactions she has ever had was 15 years ago (2006), she had a CAT scan and experienced hives the next day due to the contrast medium. She thought it had since been changed as she had had it twice since then and was given diphenhydramine hydrochloride (BENADRYL) but experienced nothing again. Concomitant medication included: ongoing dulaglutide (TRULICITY) for diabetes type 2 and ongoing oral medication (unspecified) for gout. No additional vaccines administered on same date of BNT162B2. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) single dose for COVID-19 immunization on 19Dec2020 around 12pm and 2 pm. The patient previously got the flu shot (unspecified) every year, 3 years ago (in 2018) she got the shingles vaccine and had also had the pneumonia vaccine (in 2018) but never experienced anything from those products. The patient previously took allopurinol for pulmonary emboli and had had no reoccurrence. She took warfarin for short of breath. The patient had flushing on 05Jan2021, she was hot and turned red like a cherry. She had an episode where she felt really hot like hot flashes or almost like she was flushed. Her face was red as beet and her arm and hands were red, this lasted about an hour and she took ibuprofen (ADVIL) for it. It seemed to be resolved but had come and gone through the night. She was up checking on her puppies so that was how she noticed. She had taken her temperature and it had been 97.6-98.1 which was normal for her, but she was still getting the hot flashes and flushing. She felt feverish and it was not a rash, she just felt flushed. After the vaccine, the patient reported soreness in the arm on 05Jan2021. The patient was experiencing tingling in hands and feet (mostly in feet) on 05Jan2021 and they feel cold. Tingling started about 45 minutes to an hour after the dose. The first time lasted 3-4 hours and then went away. It came back in the middle of the night for a couple hours and then again this morning. This morning it had been going on for 2-3 hours and was still going on right now; it started about 6:30am-7am. They feel cold but her feet were really cold. She had socks and slippers on, but they didn't seem to get warm. She went on to explain that her hands and feet have profusion. During this she had checked her pulse ox (oximetry) related to her cold hands and it had been 92-95% (on unknown date) which was good. She had also checked her pedal pulses even though they were cold, and a little they were a little on white side, they blanch although might be a little slow but nothing alarming. The patient had a little headache on 05Jan2021. Other than that, the patient felt fine. No emergency room or physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events flushing, hot/ felt really hot, soreness in the arm, tingling in hands and feet (mostly in feet) and they feel cold was not resolved; outcome of the other events was unknown. Causality assessment between the Pfizer product (BNT162B2) and the events (tingling, flushing, soreness in the arm) per the reporter was reported as related.

Other Meds: TRULICITY

Current Illness: Gout (Verbatim: Gout); Type 2 diabetes mellitus (Verbatim: diabetes type 2)

ID: 0944201
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Name: Covid test; Test Result: Positive

Allergies:

Symptoms: a positive Covid test after receiving their first dose; a positive Covid test after receiving their first dose; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 06Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable other healthcare professional (student pharmacist) and a contactable pharmacist reported that a patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration, on an unspecified date, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter that works at a hospital pharmacy called about a patient that received their first dosage of COVID-19 vaccine who had a positive COVID test on an unspecified date after receiving their first dose of the vaccine. They wanted to know hoe to proceed and if they needed the second dose. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0944202
Sex: F
Age: 51
State: PA

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies: Sulfa, Indocin

Symptoms: Vacccinated at 9:30am. On 1/12/2021 7:30am started with flush face, nausea, dizzy, fever, headache and chills

Other Meds: Synthyroid,, multivitamin, liinopril, B12, d3, zinc, VIt C

Current Illness: none

ID: 0944203
Sex: F
Age:
State: NY

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210106; Test Name: swabbed for COVID; Result Unstructured Data: Test Result:Positive; Comments: She was swabbed for COVID yesterday and tested positive.

Allergies:

Symptoms: covid a week after the1st dose of the vaccine. When to get the 2nd dose?/tested positive for COVID; covid a week after the1st dose of the vaccine. When to get the 2nd dose?/tested positive for COVID; body aches; fever; Headache; This is a spontaneous report from a contactable physician. A 31-year-old female patient (healthcare worker) received the 1st dose of bnt162b2 (BNT162B2) at single dose in Dec2020 (9 days before 07Jan2021) for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the 1st dose of the COVID vaccine 9 days before 07Jan2021 and got a headache afterward in Dec2020. After 6 days, in Jan2021 the patient had a worse headache, body aches, and fever. She was swabbed for COVID on 06Jan2021 and tested positive. The reporter wanted to know what to do about the 2nd dose. The outcome of events was unknown. A product complaint was filed. information about lot and batch number was requested.

Other Meds:

Current Illness:

ID: 0944204
Sex: F
Age:
State: CA

Vax Date: 12/19/2020
Onset Date: 12/27/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20201227; Test Name: Covid test; Result Unstructured Data: Test Result:positive

Allergies:

Symptoms: tested positive for covid/headache, ever, cough, diarrhea; tested positive for covid/headache, ever, cough, diarrhea; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, expiration date: 20Mar2021), via an unspecified route of administration on 19Dec2020 16:15 at left arm, at single dose for covid-19 immunization. Medical history included hysterectomy in 2010, pulmonary Embolism in 2010, gallbladder removed on an unknown date. There were no concomitant medications. The patient received 1st dose 19Dec2020, she was supposed to get her second dose, but tested positive for covid. She thought she had side effects after vaccine, she began with a headache, fever a week later and thought they were from the vaccine, but then her sister-in-law was positive for COVID, her sister-in-law passed away from covid virus. Then the patient, her mom, and husband tested positive for COVID. She tested positive for COVID on 27Dec2020. She developed symptoms of COVID on 27Dec2020. It was exactly one week after receiving the first dose. It was also reported that she got tested on the 30th (as reported) and received results on 31Dec2020 that she was positive. After she got sick she has taken Mucinex. Day eleven, she is doing ok, but has a little cough. No more fever. Sometimes she has diarrhea but today no diarrhea. The patient asked if she can get her second dose of the covid vaccine on day 24. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 0944205
Sex: M
Age: 49
State: IN

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: None

Allergies: Sulfa

Symptoms: Swollen left arm pit, achy feeling and headache

Other Meds: omeprazole

Current Illness: None

ID: 0944206
Sex: M
Age: 54
State: CA

Vax Date: 01/04/2021
Onset Date: 01/08/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: 1/14/21. CK, CRP, CMP, CBC, CK 6000. elevated liver enzymes.

Allergies: none

Symptoms: 1. Within 24 hrs post vaccination 1/5/2021 severe headache, malaise symptoms. 2. 1/8/2021 onset of severe back pain. 3. 1/13/2021 severe back pain continued, unrelieved by NSAIDS and Acetaminophen. 4. 1/14/2021 non-traumatic rhabdomyolysis possibly due to COVID-19 vaccine diagnosis. Diagnosis was made in hospital Emergency Department.

Other Meds: vitamin b,c, coQ10.

Current Illness: none

ID: 0944207
Sex: F
Age:
State: MI

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210107; Test Name: fever; Result Unstructured Data: Test Result:99.3 Fahrenheit; Test Date: 20210107; Test Name: fever; Result Unstructured Data: Test Result:100.6 Fahrenheit

Allergies:

Symptoms: chills; body aches; cold; fever; pain at injection site; This is a spontaneous report from a Pfizer-sponsored Program Pfizer First Connect. A contactable consumer (patient herself) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunization. Patient had a history of COVID in Nov2020. Concomitant medication included levothyroxine sodium (SYNTHROID) (for twenty some years), bupropion hydrochloride (WELLBUTRIN) (for about a year), naltrexone (for about a year), all from an unspecified date and ongoing. The patient got the vaccine yesterday (06Jan2021). Patient experienced chills, body aches, cold, fever, and pain at the injection site started at 10 am on 07Jan2021. The fever has went up a little since this morning, but everything else has stayed the same. Her fever was 100.6 degrees Fahrenheit now. Earlier this morning it was 99.3 degrees Fahrenheit. Outcome of events were not recovered.

Other Meds: SYNTHROID; WELLBUTRIN;

Current Illness:

ID: 0944208
Sex: F
Age:
State: FL

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0944209
Sex: F
Age: 48
State: MD

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: After she left the vaccine site she began feeling lightheaded. She was wheeled back to the clinic, given a dose of epi, and IV fluids. Her BP was elevated. EMS was called and she was transported to the ED, released several hours later.

Other Meds: blood pressure medication

Current Illness:

ID: 0944210
Sex: F
Age:
State: MA

Vax Date: 01/03/2021
Onset Date: 01/03/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210103; Test Name: body temperature; Result Unstructured Data: Test Result:101; Test Date: 2020; Test Name: COVID-19; Test Result: Positive ; Comments: the patient had a positive COVID test earlier, she thinks it was maybe 3 to 4 months ago

Allergies:

Symptoms: The patient had an ongoing medical history of Crohn's disease/Concomitant medication included vedolizumab (ENTYVIO) for Crohn's disease; shortness of breath; difficulty swallowing; fever; headache; nausea; she was feeling as if her throat was closing; Chest tightness; This is a spontaneous report from a contactable physician reporting for a patient. A 34-year-old female patient received the first dose of BNT162B2 (COIVD-19 Vaccine) , via an unspecified route of administration on 03Jan2021 at single dose for covid-19 immunisation. Medical history included Crohn's disease from an unknown date and unknown if ongoing, COVID-19 in 2020 to an unknown date and unknown if ongoing. Concomitant medication included vedolizumab (ENTYVIO) for Crohn's disease. The reporter is a physician who is reporting and AE for a patient who received the vaccine and subsequently developed symptoms including short of breath, fever, headache, nausea, difficulty swallowing with seriousness criteria of Medically significant on 03Jan2021. The patient self-medicated with benadryl and symptoms resolved briefly but then went to urgent care with re-occurring symptoms and was prescribed prednisone. Caller states the patient's symptoms have resolved. She is calling to get more information to determine if the patient should receive the second dose. The reporter further stated that she has a patient who received her first shot, clarified as the COVID-19 Vaccine. About an hour and 45 minutes later, the patient had shortness of breath and then later had a fever, headache and nausea. It was later that night when the patient had a fever. The patient had difficulty swallowing which worsen; she was feeling as if her throat was closing. The patient is a nurse, so she self medicated with Benadryl. After taking the Benadryl, the patient was better in the early morning. When the doctor's office opened, the patient called and was having similar symptoms, clarified as all the symptoms mentioned above. The patient went to the urgent care where she received more Benadryl and was started on prednisone. Caller did not know the dose of prednisone the patient had received. After that, the patient started feeling better. The patient's second dose of the COVID19 Vaccine is due around 24 to 26Jan2021. The patient has not called the doctor/caller back. The caller assumes that the patient has recovered but could not be certain. Caller added that the patient also experienced chest tightness when she was having shortness of breath. The patient's fever was 101 on 03Jan2021. The patient was not drooling with her difficulty swallowing. Caller stated that the patient had a positive COVID test earlier, she thinks it was maybe 3 to 4 months ago (in 2020). The patient has not received another COVID test since she received the first dose of the COVID-19 vaccine to the caller's knowledge. Reporting physician is an internal medicine physician. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported short of breath, fever, headache, nausea, difficulty swallowing, throat closing, chest tightness, and the administration of COVID 19 vaccine, BNT162B2, based on the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds: ENTYVIO

Current Illness:

ID: 0944211
Sex: F
Age:
State: NY

Vax Date: 01/05/2021
Onset Date: 01/01/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: reported hoarseness in the voice; itching and burning sensation around the throat; shortness of breath; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 17:00 at single dose in the right arm for COVID-19 immunisation. The patient had anaplasias to penicillin and COVID. The concomitant medications was none. The patient experienced hoarseness in the voice on 07Jan2021, itching and burning sensation around the throat in Jan2021. She had shortness of breath in Jan2021 related to COVID-19 infection. She has had COVID already so she isn't worried about that but wants to know if it is related to the vaccine or not, if this is something she needs to be aware of. The event started and gradually was getting worse. She had her inhaler from when she had COVID. The patient clarified she has also had some shortness of breath but this has been going on since having COVID. She did try the inhaler for the hoarseness and shortness of breath she had. She has been interment shortness of breath since having COVID and she is being tested for lung damage. The inhaler didn't change the hoarseness or shortness of breath. The product used was salbutamol (ALBUTEROL), Lot: PK0358, Expiry: Jun2022, NDC: 0093317431. She has had no reactions to vaccines previously, she had no vaccines on the day of or in the previous 4 weeks. She has not been to the doctor or ER related to the event. The outcome of the event hoarseness in the voice was not recovered. The outcome of other events was unknown.

Other Meds:

Current Illness:

ID: 0944212
Sex: M
Age: 76
State: NY

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: FS and BMP unremarkable

Allergies: NKDA

Symptoms: Two seizures of Left arm shaking and non-responsiveness with urinary voiding and post-ictal state the day after vaccination

Other Meds: citalopram, acetaminophen, novolog, basaglar, senna, docusate, lisinopril

Current Illness:

ID: 0944213
Sex: F
Age:
State:

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:99.6; Comments: Low grade

Allergies:

Symptoms: She had only planned on her arm being sore; head cold/she has a really bad headcold; swollen eye; runny eye; sneezing; runny nose; ear infection; low grade fever; This is a spontaneous report from a contactable consumer. This consumer reported for self that the female patient of unknown age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via unknown route of administration on 05Jan2021 around 09:00 am at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient would like to know what the duration of reported side effects she's experiencing since getting vaccine will be. Symptoms experiencing are : head cold, swollen eye, runny eye, sneezing, runny nose, feels like she has ear infection, low grade fever. Symptoms have been going on for 3 days. This X-ray Technician is the patient. She reported starting afternoon of 05Jan2021 she had onset of: feels like she has a really bad head cold; swollen eye; runny eye; runny nose; sneezing; feels like she has an ear infection; low grade fever. She asked what the expected duration of these side effects is, how long she is going to be sick with these. She had only planned on her arm being sore. This has not been just a little, these events have been really bad. Further described Low grade fever as just like 99.6. She has been doing Tylenol and Bayer Aspirin. When she had the Flu vaccine she felt kind of tired for a day; like a little cold; sneezing for a day. The outcome of the event She had only planned on her arm being sore was unknown. The outcome of the other events was not recovered. Information on the LOT/Batch number has been requested.

Other Meds:

Current Illness:

ID: 0944214
Sex: F
Age:
State: IL

Vax Date: 12/17/2020
Onset Date:
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hypereosinophilia (31%) asymptomatic; This is a spontaneous report from a contactable physician (patient herself). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), via an unspecified route of administration in the left arm on 17Dec2020 16:30 at a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and penicillin allergies. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced hypereosinophilia (31%) asymptomatic on an unspecified date. It was unknown if treatment was given as a result of the event. Clinical outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0944215
Sex: F
Age: 37
State: MD

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: swollen, red warm at injection site

Other Meds:

Current Illness:

ID: 0944216
Sex: F
Age:
State: CA

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210107; Test Name: Nasal Swab post vaccination for Covid 19; Result Unstructured Data: Test Result:Pending

Allergies:

Symptoms: headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]; ; VITAMIN D [COLECALCIFEROL]; APPLE CIDER

Current Illness:

ID: 0944217
Sex: F
Age: 29
State: CA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Chills, headache, diarrhea, nausea

Other Meds:

Current Illness:

ID: 0944218
Sex: F
Age:
State:

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20201222; Test Name: heartbeat; Result Unstructured Data: Test Result:fast; Test Name: a lot of tests; Result Unstructured Data: Test Result:unknown resultes; Test Name: oxygen saturation; Result Unstructured Data: Test Result:dropped to 92; Test Name: oxygen saturation; Result Unstructured Data: Test Result:usually 98 or 100

Allergies:

Symptoms: trouble breathing; She had bad pain in her chest; Her oxygen saturation dropped to 92 and it is usually 98 or 100; not been feeling well; A fast heartbeat 5-10 minutes after initial dose; This is a spontaneous report from a contactable healthcare professional (dental assistant) reporting for self. This female patient with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously had reactions with the flu shot in the past for immunisation and she only was able to take the vegan version of the flu shot due to the egg content in the regular version of the flu shot. She also stated not being able to take the flu shot in the arm, leg, hip etc. Patient stated she was scheduled to take her second dose of vaccine tomorrow. She received the first dose on 22Dec2020. She stated she was in the ER on Monday for 5 hours because she was unable to see her primary care physician because his office was filled with patients with Covid and they could not provide her with guidance. She stated after receiving the first dose of vaccine she had not been feeling well ever since. Stated she had had trouble breathing and this took her by surprise. She had bad pain in her chest and a fast heartbeat 5-10 minutes after initial dose (on 22Dec2020). Her oxygen saturation dropped to 92 and it was usually 98 or 100. She stated something inhibited her ability to breathe and this scared her because she was healthy prior to the vaccine and never been in hospital and wasn't born in the hospital. She stated the condition she was diagnosed with will take 6-12 months for her to recover from and go back to normal. She stated during her ER room visit there were a lot of tests done. She would like to know if she should receive the second dose of the vaccine. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dyspnea, chest pain, oxygen saturation decreased and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, arterial blood gas and pulmonary function tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0944219
Sex: M
Age: 90
State: MN

Vax Date: 01/07/2021
Onset Date: 01/12/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Resident has a history of strokes with his most recent stroke being on 2/15/20 (Acute Ischemic Stroke).

Allergies: No known allergies

Symptoms: On 1/12/20 resident woke up and was not able to stand in the E-Z stand. E-Z lift was needed. In addition he needed assistance with eating. At that time VS were stable, equal hand grasp noted, and no further concerns. Around 3pm resident became flaccid on the left side of his face and speech became mumbled. Hand grasp was equal at that time and VS were stable, but B/P was elevated compared to previous recordings earlier in the day. Family did not want him sent to the hospital and asked for comfort cares. Hospice referral obtained and he will be admitted to hospice in the near future. Resident's left side of face has improved within the last 48 hours. He remains total assist with all cares.

Other Meds: Systane drops, Lipitor, Mirtazapine, Digoxin, Lasix, Aspirin, Cymbalta, Trazodone, Levothyroxine, Depakote, Biofreeze, Senna, Neurontin, Risperidone, Flovent HFA,

Current Illness: Resident has slowly been declining over the past several months. Physically he went from being able to walk, to needing the E-Z stand to transfer and most recently has become total assist with all ADL cares.

ID: 0944220
Sex: F
Age:
State:

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: having gas/bloating since receiving the vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 06Jan2021 at 10:30 AM at a single dose on the right arm for COVID-19 immunization. The patient was vaccinated in the nursing home/senior living facility. The patient was not administered any other vaccine in four weeks. The patient's medical history was not reported. Concomitant medication included levothyroxine (manufacturer unknown), vitamin d (manufacturer unknown), zinc (manufacturer unknown), Claritin (unspecified generic name) and unspecified vitamins. The patient previously took amoxicillin and experienced allergies. It was reported that the patient has been having gas/bloating since receiving the vaccine on 07Jan2021 at 16:00 (reported as 4:00 PM). The patient received over the counter gas medicine as treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: ; VITAMIN D [VITAMIN D NOS];

Current Illness:

ID: 0944221
Sex: F
Age: 27
State: CT

Vax Date: 12/30/2020
Onset Date: 01/06/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: None

Allergies: NKA

Symptoms: 7 days after initial IM injection--pain, pruritus, redness and warmth of left deltoid. Area felt indurated on palpation. Resolved after 2 days. Highly localized to injection site.

Other Meds: Sertraline Lessina birth control

Current Illness: None

ID: 0944222
Sex: F
Age:
State: MS

Vax Date: 12/30/2020
Onset Date: 01/02/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.

Other Meds: HCTZ; VALTREX

Current Illness:

ID: 0944223
Sex: F
Age: 53
State: PA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: just physical assessments

Allergies: sulfa, ciprofloxacin, ACE inhibitors erythromycin, losartan

Symptoms: the reaction began about 45 minutes after Moderna vaccine. I began to notice tingling in my hands and feet first. My right foot felt a little stiff when picking it up from the gas to the break while driving home. I noticed shortly after I arrived home itching and tingling all over and more pronounced picking, burning, numbness in my mouth(tongue and chin), hands and feet, No rash, no shortness of breath. I took a Benadryl hoping just a mild reaction that would clear up. Next morning my feet and hands woke me up from the tingling and cramping. Other symptoms off and on were spasms in my feet and pain in index and middle fingers when touching cold. I called my doctor on Monday morning to get in for an appointment after I was awakened with some cramping in my calves and was more concerned. Was told if it worsened or I had any SOB or weakness in extremities to go to the ER. My reflexes were checked and normal and no weakness in my muscles. No other tests done at that time. The symptoms persist with buzzing feeling in them off and on, feeling of stiffness and stabbing feeling on occasion, no more cramps in calves. It remains mostly ankles to feet but some numbness to below knees. Hands, no further than wrist, along with chin and tongue remain numb and tingling at times.

Other Meds: metformin, triamterene-HCTZ, levothyroxine, vitamin C 500 mg, iron 65 mg, loratadine 10 mg, Tylenol , tramadol

Current Illness: no

ID: 0944224
Sex: F
Age:
State: UT

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Soreness at injection site; Soreness radiated down to elbow and thumb/Joint pain; Soreness radiated down to elbow and thumb; Intense body aches; chills; This is a spontaneous report from a contactable other nurse (patient). A 32-year-old female patient received the first dose of BNT162b2 (Lot number: EK9231), via an unspecified route of administration at right arm on 04Jan2021 13:30 at single dose for covid-19 immunization. Medical history included birth control. Concomitant medication included probiotics, ethinylestradiol, norethisterone acetate (JUNEL) for birth control. The patient experienced soreness at injection site on 04Jan2021 18:00; soreness radiated down to elbow and thumb, Intense body aches, joint pain, chills on 04Jan2021. The patient received the treatment Acetaminophen 1000mg every 6 hours and Ibuprofen 400mg for events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.

Other Meds: ; JUNEL

Current Illness:

ID: 0944225
Sex: F
Age: 21
State:

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Had previous non- anaphylactic reaction with 1st dose of Pfizer vaccine. Consulted her physician and was encouraged to get the 2nd dose. Within 5 minutes of 2nd dose vaccination, patient experienced numbness and tingling in the face. Vital signs within normal linits, but worsening paresthesias. Sent to ED. O2 sat in ED 99%. No shortness of breath. Noted with scattered hives to torso. Given Benadryl and famotidine and improved.

Other Meds:

Current Illness:

ID: 0944226
Sex: F
Age:
State: PA

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Name: T-max 102 F, fever lasted 48 hours, did not go below 100; Result Unstructured Data: Test Result:102 Fahrenheit; Test Name: T-max 102 F, fever lasted 48 hours, did not go below 100; Result Unstructured Data: Test Result:100 Fahrenheit

Allergies:

Symptoms: Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; Headache, T-max 102 F, fever lasted 48 hours, did not go below 100 despite antipyretics. Body aches/rigors, loss of appetite.; This is a spontaneous report from a contactable nurse. A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (anatomical location: left arm) on 29Dec2020 at a single dose for COVID-19 immunization. Medical history included known allergies to sulfa. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient previously took levofloxacin (LEVOQUIN) and minocycline and experienced allergies. The patient experienced headache, body aches/rigors, loss of appetite and T-max 102 F (fever lasted 48 hours, did not go below 100 despite antipyretics) on 30Dec2020. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit then 100 fahrenheit on unspecified dates. Therapeutic measures were taken as a result of fever. The outcome of the events was recovered on an unspecified date.

Other Meds: BENADRYL

Current Illness:

ID: 0944227
Sex: F
Age: 32
State: TX

Vax Date: 01/06/2021
Onset Date: 01/12/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies: Minocycline

Symptoms: Itchy,swollen, hot to touch injection site

Other Meds: Bupropion Xl 150

Current Illness:

ID: 0944228
Sex: F
Age:
State: VA

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20210107; Test Name: Fever; Result Unstructured Data: Test Result:101.1

Allergies:

Symptoms: headaches for rest of day; severe dizziness; chest palpitations; extreme muscle weakness; projectile vomiting- all x15 minutes; fever of 101.1; general fatigue; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176), intramuscular on 06Jan2021 14:30 at single dose at left arm for covid-19 immunization. Medical history included anxiety, osteoarthritis from an unknown date and unknown if ongoing. No known allergies to medications, food, or other products. Concomitant medications in two weeks included escitalopram oxalate (LEXAPRO), paracetamol (TYLENOL), ibuprofen. Patient previously received first dose of bnt162b2 (Batch/lot number: EH9899) intramuscular on 16Dec2020 14:45 at single dose at right arm for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. The patient experienced severe dizziness, chest palpitations, extreme muscle weakness, projectile vomiting- all x15 minutes, followed by fever of 101.1 after paracetamol, general fatigue, headaches for rest of day from 07Jan2021 08:30 am with outcome of recovering. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report is considered as non-serious.

Other Meds: LEXAPRO; TYLENOL;

Current Illness:

ID: 0944229
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Name: Covid-19 test; Result Unstructured Data: Test Result:develops symptomatic covid; Comments: receives dose #1 and develops symptomatic covid-19 prior to dose #2

Allergies:

Symptoms: develops symptomatic covid; develops symptomatic covid; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This physician reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed symptomatic Covid on an unspecified date. The patient received dose #1 of a Covid-19 vaccine and contracted Covid-19 prior to dose #2. The patient underwent lab test which included Covid-19 test in which he/she developed a symptomatic Covid-19 on an unknown date. Outcome of the event was unknown. Information about batch/lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021014755 Same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 0944230
Sex: F
Age: 48
State: CA

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Slight dizziness 20-25 mins after, achy arm (about 1 and 1/2 days) and minor headaches for about half day

Other Meds:

Current Illness:

ID: 0944231
Sex: F
Age:
State: GA

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20201222; Test Name: Vital signs; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptoms: flushed; hives; tongue felt "thick"; the lump in my throat feels bigger; This is a spontaneous report received from a contactable pharmacist. A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0142), via an unspecified route of administration in the left arm on 22Dec2020 (at the age of 23-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: allergies to medications, food, or other products (unspecified). It was unknown if the patient was pregnant at the time of vaccination. The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccine within 4 weeks prior to the vaccine. On 22Dec2020, approximately 8 minutes after vaccine administration, the patient began feeling flushed. She reported to the observation area, and the registered nurse noted hives on her left neck (22Dec2020). The patient was brought back for closer monitoring. The doctor evaluated the patient. Vital signs were monitored every 5 minutes (22Dec2020). The patient was given 50 mg diphenhydramine (BENADRYL) orally. Some improvement was noted in hives; however, the patient began to state her tongue felt "thick" and "the lump in my throat feels bigger" (both on 22Dec2020). Per doctor, 0.3 mg epinephrine (MANUFACTURER UNKNOWN) given intramuscularly with rapid improvement in hives. The patient reported feeling some improvement as well. The patient was taken to the emergency department for ongoing observation. The patient was released from emergency department after observation. The clinical outcome of flushed, hives, tongue felt "thick", and "the lump in my throat feels bigger" was recovered on an unspecified date.; Sender's Comments: Based on the compatible time association, the events flushing, urticaria, tong disorder, sensation of foreign body are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0944232
Sex: F
Age: 44
State: TN

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: COVID-19 positive

Allergies: Augmentin, Sulfa, Penicillin

Symptoms: Later that evening on the 23rd I began having chills which lasted for about an hour. The next day I lost my sense of smell which lasted about 1.5 week and my arm was sore, heavy and red at the injection site. The soreness and the feeling of heaviness ended the next day but the redness stayed for about 5 days and changed to a bruise which then stayed for about 1 another week. On the 29th I was given a COVID-19 test which came back positive. I noticed when I lay flat I cough alot but when I prop myself up I dont.

Other Meds: no

Current Illness: seasonal allergies

ID: 0944233
Sex: F
Age:
State:

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Itchy on her right arm and upper right torso area; Dizzy and lightheaded; This is a spontaneous report from a contactable nurse (patient). A 36-year-old-female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO140), via an unspecified route of administration in right arm, on 06Jan2021 at 08:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to gluten and penicillin (PCN). There were no concomitant medications. The patient previously took cefaclor (CECLOR) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in the patient's workplace clinic. The first dose was given at 08:30 on 06Jan2021. A few minutes after, the patient became dizzy and lightheaded for what seemed like a minute or two and then she was fine for the remainder of her 15-minute observation. Around 17:00 that day, the patient became itchy on her right arm and upper right torso area, no rash or swelling was noted. Itching subsided around 20:00 - almost 12 hours post-vaccine. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 06Jan2021 ("Itchy on her right arm and upper right torso area" at 20:00).

Other Meds:

Current Illness:

ID: 0944234
Sex: F
Age:
State: MN

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: soreness at injection site by the end of day; This is a spontaneous report from a non-contactable other HCP (patient). This 56 year-old female reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231 and Expiration date were not reported) on 05Jan2021 15:00 (at the age of 56-years) as single dose, unspecified route, left arm for COVID-19 immunisation. Medical history included known allergy to latex, wheat intolerance, and seasonal allergies, and hypothyroidism. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications include levothyroxine (LEVOTHYROXINE), colecalciferol (VIT D3), ascorbic acid, copper, tocopheryl acetate, xantofyl, zinc (OCUVIT) and zinc (ZINC). Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 05Jan2021 at 21:00 AM the patient experienced soreness at injection site by the end of day. The patient did not received treatment as a result of the event. The outcome of soreness at injection site by the end of day was recovered with sequele. No follow-up attempts are possible. No further information is expected.

Other Meds: ; VIT D3; OCUVIT [ASCORBIC ACID;COPPER;TOCOPHERYL ACETATE;XANTOFYL;ZINC];

Current Illness:

ID: 0944235
Sex: M
Age:
State: GA

Vax Date: 12/22/2020
Onset Date: 12/25/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: Covid swab; Test Result: Negative

Allergies:

Symptoms: fevers; night sweats; aphthous ulcers in his mouth; difficulty eating; difficulty eating and talking; This is a spontaneous report from a pharmacist. This adult male patient of unspecified age (18-64 Years) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142 and Expiration date was not reported) on 22Dec2020 15:15 (at unspecified age) as single dose, unspecified route for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Concomitant medications were not reported. Since the vaccination, it was unknown if the patient has tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to BNT162B2. On 25Dec2020 began having fevers, night sweats, and aphthous ulcers in his mouth so severe that he has difficulty eating and talking. It was unknown if the patient received treatment as a result of the events. Lab data included Covid swab on 28Dec2020 which was negative. The outcome of event fevers was unknown, night sweats was unknown, and aphthous ulcers in his mouth so severe was unknown, he has difficulty eating was unknown and difficulty talking was unknown.

Other Meds:

Current Illness:

ID: 0944236
Sex: M
Age: 43
State: MI

Vax Date: 12/27/2020
Onset Date: 12/27/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data: CT Scan

Allergies: None Known

Symptoms: New onset seizure approximately 20 hours post vaccination

Other Meds: Flexeril

Current Illness: None known

ID: 0944237
Sex: U
Age:
State: NC

Vax Date: 12/17/2020
Onset Date: 12/01/2020
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies:

Symptoms: very mild tightening of my throat; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer COVID-19 vaccine on 17Dec2020. Two and a half (2 1/2) hours post inoculation in Dec2020, patient experienced very mild tightening of throat that was resolved with Children's liquid Benadryl. Due to the contraindications/precautions from the agency, patient's agency refused to give patient the 2nd vaccine. Patient's reaction was extremely mild. Patient stated "I'm looking for a clinical trial that would like to investigate ways to minimize adverse reactions upon receiving the 2nd dose of this vaccine (i.e. pre-medicate with Benadryl a certain amount of time prior to the vaccine or etc)". Outcome of the event was resolved on an unspecified date. Information on the LOT/Batch number has been requested.

Other Meds:

Current Illness:

ID: 0944238
Sex: M
Age: 46
State: NJ

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/14/2021
Hospital:

Lab Data:

Allergies: no known allergies

Symptoms: Error: Wrong Patient (documentation in EMR); symptoms lasted 0 days

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm